Model Number 595000-001 |
Device Problem
Difficult to Insert (1316)
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Patient Problem
No Patient Involvement (2645)
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Event Date 11/06/2019 |
Event Type
malfunction
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Manufacturer Narrative
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This alleged failure mode poses a low risk to a patient because the issue was observed when the freedom driver was not supporting a patient.The freedom driver will be returned to syncardia for evaluation.The results of the investigation will be provided in a follow-up mdr.(b)(4).
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Event Description
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The freedom driver was not supporting a patient.The customer, a syncardia certified hospital, reported that during freedom driver system check, there was difficulty when inserting the freedom onboard battery into the battery well.
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Manufacturer Narrative
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During investigation testing, the customer-reported issue was confirmed as there was difficulty inserting a freedom onboard battery into the right battery well.Despite this insertion difficulty, the freedom driver passed all functional testing criteria.The root cause of the reported issue was determined to be a malfunction of the right battery latch and the battery latch bars.This issue will continue to be monitored and trended as part of the customer experience process.Syncardia has completed its evaluation of this complaint and is closing this file.(b)(4) follow-up report 1.
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Search Alerts/Recalls
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